HealthyNCT01389492
The Effect of Meat and Food Drived Polyphenols on Oxidize LDL Level
A study testing frozen meat cutlets meal and meat meals in people with Healthy, run by Hadassah Medical Organization at 1 site in Israel.
Trial summary
The postprandial increase in MDA level following meat meal could cause modification to LDL particles in healthy volunteers. Co-consumption of food drived polyphenols with the meat will result in a significant decrease in LDL modification. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- frozen meat cutlets meal and meat meals
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteIsrael
- Study dates
- Oct 2010to May 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adults, normal BMI
Who cannot join
- Metabolic disorders
- Smokers
- Drinkers
- Taking nutritional supplement
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Nutritional Study:The Effect of Meat and Food Drived Polyphenols on Oxidize LDL Level
The postprandial increase in MDA level following meat meal could cause modification to LDL particles in healthy volunteers. Co-consumption of food drived polyphenols with the meat will result in a significant decrease in LDL modification.
- Conditions
- Healthy
- Being tested
- frozen meat cutlets meal, meat meals
- Keywords
- meat, LDL, MDA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
frozen meat cutlets mealOther
250 g of meat cutlets
meat mealsOther
250 g of meat meal for 4 days
| Study group | Role | What they receive |
|---|---|---|
| frozen meat | Other | 250 g of frozen meat meal for 4 days Receives: Other: frozen meat cutlets meal; Other: meat meals |
| frozen meat and wine | Other | 250 g of frozen meat and red wine for 4 days Receives: Other: frozen meat cutlets meal; Other: meat meals |
| fresh meat | Other | 250 g of fresh meat meal Receives: Other: frozen meat cutlets meal; Other: meat meals |
| fresh meat and wine | Other | 250 g of fresh meat meal Receives: Other: frozen meat cutlets meal; Other: meat meals |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in plasma MDA levels following meat meal
After an overnight fast baseline (0 h) fasting blood sample (10 ml) was collected in EDTA-treated tubes. The subjects then ate a test meal within 30 min. Blood samples (10 ml) were drawn 3 and 6 h after the meal was eaten. Serum was separated from whole blood by centrifugation (910 g, 15 min), and MDA was evaluated by HPLC in plasma samples
Measured: Fasting before meal and 3, and 6 h postprandial, and fasting levels
Changes in MDA concentration on LDL fraction following meat meals
Subject consumed the test meals for 4 days. Day 1, (0 h) fasting blood sample (10 ml) was collected in EDTA-treated tubes. The sbjects then ate a test meal within 30 min. Blood samples (10 ml) were drawn 3 h after the meal was eaten. Blood was collected at day 4, 3 h after the meal was eaten, at the morning of day 5.Plasma LDL was isolated using a single discontinuous density gradient ultracentrifugation. The protein concentration was determined based on the method of Bradford. MDA concentration was evaluated by HPLC.
Measured: Fasting, before meal was eaten, 3 h following meal, at day 4, 3 h following meal consumption, and day 5 following over nigth fast
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2011 (estimated)
- Study startOct 2010
- Primary completionFeb 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Investigators
- Shlomit Gorelik, PhD, Study director, Hebrew University of Jerusalem
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01389492
- Sponsor's protocol ID
- MWPP09-HMO-CTIL
- Status last verified
- Oct 2009
- First submitted
- 3 Jul 2011
- Last updated
- 8 Jul 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutritional Study:The Effect of Meat and Food Drived Polyphenols on Oxidize LDL Level
- ClinicalTrials.gov ID
- NCT01389492
- Acronym / sponsor ID
- MWPP09-HMO-CTIL
- Conditions
- Healthy
- Keywords
- meat, LDL, MDA
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Feb 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 8 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The postprandial increase in MDA level following meat meal could cause modification to LDL particles in healthy volunteers. Co-consumption of food drived polyphenols with the meat will result in a significant decrease in LDL modification.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| frozen meat | Other | Other: frozen meat cutlets meal, Other: meat meals250 g of frozen meat meal for 4 days |
| frozen meat and wine | Other | Other: frozen meat cutlets meal, Other: meat meals250 g of frozen meat and red wine for 4 days |
| fresh meat | Other | Other: frozen meat cutlets meal, Other: meat meals250 g of fresh meat meal |
| fresh meat and wine | Other | Other: frozen meat cutlets meal, Other: meat meals250 g of fresh meat meal |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy adults, normal BMI
Key exclusion criteria (4 listed)
- Metabolic disorders
- Smokers
- Drinkers
- Taking nutritional supplement
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| frozen meat cutlets meal250 g of meat cutlets | Other | fresh meat, fresh meat and wine, frozen meat, frozen meat and wine |
| meat meals250 g of meat meal for 4 days | Other | fresh meat, fresh meat and wine, frozen meat, frozen meat and wine |
Primary outcome
Change in plasma MDA levels following meat meal
Time frame: Fasting before meal and 3, and 6 h postprandial, and fasting levels
After an overnight fast baseline (0 h) fasting blood sample (10 ml) was collected in EDTA-treated tubes. The subjects then ate a test meal within 30 min. Blood samples (10 ml) were drawn 3 and 6 h after the meal was eaten. Serum was separated from whole blood by centrifugation (910 g, 15 min), and MDA was evaluated by HPLC in plasma samples
Changes in MDA concentration on LDL fraction following meat meals
Time frame: Fasting, before meal was eaten, 3 h following meal, at day 4, 3 h following meal consumption, and day 5 following over nigth fast
Subject consumed the test meals for 4 days. Day 1, (0 h) fasting blood sample (10 ml) was collected in EDTA-treated tubes. The sbjects then ate a test meal within 30 min. Blood samples (10 ml) were drawn 3 h after the meal was eaten. Blood was collected at day 4, 3 h after the meal was eaten, at the morning of day 5.Plasma LDL was isolated using a single discontinuous density gradient ultracentrifugation. The protein concentration was determined based on the method of Bradford. MDA concentration was evaluated by HPLC.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2011.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shlomit Gorelik, PhD study director
Hebrew University of Jerusalem
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing frozen meat cutlets meal and meat meals in people with Healthy, run by Hadassah Medical Organization at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in plasma MDA levels following meat meal (time frame: Fasting before meal and 3, and 6 h postprandial, and fasting levels). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2011.